All Things Pros focuses exclusively on patent prosecution. I use PTAB decisions, and the prosecution history that led to appeal, to discuss good and bad strategies for handling 102, 103, 101 and 112 rejections. Claim construction using Broadest Reasonable Interpretation is also a major focus. And sometimes I'll discuss prosecution topics such as after-final, RCE, and restriction practice.

Tuesday, April 26, 2011

Takeaway: Ex parte Pavich involved a marking pen for surgical sites on the body. The claim on appeal was for a "one-time skin marking system", where the single use aspect was captured in the relationship between the volume of liquid in the hollow body and the volume of liquid in the marking tip: "a marking liquid carried in said hollow body, said marking liquid having a volume not greater than an amount substantially equal to said predetermined liquid carrying capacity." The single reference used in the prior art rejection disclosed 0.25 mL in the body and 0.15 mL in the tip. Although the Board acknowledged that 0.25 was 67% more than 0.15, the Board nonetheless found the volumes were "substantially equal" since the quantities involved were quite small.

1. A one-time skin marking system, comprising
a. a marking implement having a hollow body portion,
b. a marking tip extending from said marking implement, said marking tip being in fluid
communication with said hollow body portion and said marking tip having a predetermined liquid carrying capacity,
c. a marking liquid contained in said hollow body portion, said marking liquid having a volume not greater than an amount substantially equal to said predetermined liquid carrying capacity, and
d. a pressure-sensitive expedient for delivering said marking liquid to said marking tip.
(Emphasis added.)

The Examiner first rejected as anticipated by Rosen, then switched to an obviousness rejection using the same reference. The Examiner found that Rosen disclosed all elements except "having a volume not greater than ... " However, the Examiner asserted that Rosen's marking pen was for single use, and used a volume of marking liquid "sufficient to saturate the marking tip." The Examiner found it obvious to provide the claimed volume of marking liquid "in order to match the volume of the liquid to an amount sufficient to saturate the marking tip."

In the Appeal Brief, the Applicant argued that Rosen did not disclose the claimed "substantially equal" volume limitation. According to the Applicant, Rosen taught filling the body to 0.25 mL and taught a tip which absorbed 0.15 mL of the treating solution. The Applicant thus concluded that the volume of liquid in the hollow body (0.25 mL) is “approximately double the [0.15 mL] carrying capacity of the nib” rather than substantially equal as claimed.

The Applicant also explained why a POSITA would not modify Rosen to use the claimed volume, as follows:

[I]t is mere speculation that Rosen must somehow have a substantially equal amount of liquid to the liquid carrying capacity. Rosen is silent on the subject, and clearly all of the disclosure of Rosen, emphasized by the drawings, suggests the opposite, and that is Rosen has much more liquid than the liquid carrying capacity of the tip. Again, as explained above, Rosen really doesn't care about matching the liquid carrying capacity because all Rosen wants to do is flush the fluorescarnine from the tip. Thus, Rosen provides an abundance of liquid (the solvent) for that purpose. Rosen is concerned only with flushing the fluorescamine from the nib, and not limiting the amount of liquid for any reason.

In the Answer, the Examiner responded as follows:

Appellant's argument appears to rely on the premise that since the disclosure of Rosen is not expressly concerned with matching the liquid in the hollow body portion to the carrying capacity of the marking tip, one of ordinary skill in the art would not have found it obvious to do so. In response, Examiner points ... especially to the passage ... "a volume of dermatologically acceptable solvent for the furanone in the sealed solvent tube sufficient when the tube is broken to dissolve the furanone in the wick in the solvent released from the tube and saturate the wick marking nib with the resulting solution." One skilled in the art would understand that a volume of solvent (the marking liquid) substantially equal to the liquid carrying capacity of the nib would be sufficient to dissolve the furanone in the nib and saturate the nib with the resulting solution.

The Board didn't even perform an obviousness analysis, finding instead that Rosen disclosed every claim limitation. The Board's factual findings about Rosen agreed with the Applicant: 0.25 mL in the housing and 0.15 mL in the tip. However, the Board found that the Applicant had improperly characterized the body volume as being double the tip volume: "The 0.25 mL of solvent is actually only two-thirds as much more than 0.15 mL."

The Board then explained that use of "substantially' broadened the claim so that Rosen anticipated:

In addition, we note that use of words of approximation, such as “substantially,” in a patent claim implies the avoidance of a strict numerical boundary of the specified parameter. See Anchor Wall Sys., Inc. v. Rockwood Retaining Walls, Inc., 340 F.3d 1298, 1311 (Fed. Cir. 2003). Thus, in our opinion, one of ordinary skill in the art would consider the 0.25 mL volume of solvent 33 in the glass ampoule 30 of Rosen’s marking device 10 to be substantially equal to the 0.15 mL predetermined carrying capacity of the nib 50. See, e.g., In re Sinex, 309 F.2d 488, 493 (CCPA 1962) (substantially horizontal includes chamber that is inclined at 9 degrees). In support of this holding, we note that “nothing in the prosecution history of the present invention clearly limits the scope of “substantially equal” such that the adverb “substantially” does not broaden the meaning of “equal” and thus, in claiming “substantially equal,” Appellants claimed more than equal. We find that since the two volumes are relatively small, the two volumes are substantially equal.

My two cents: Most of the applications I prosecute don't claim dimensions or capactities, even relative ones, and I don't use "substantially" much. But the Board's reasoning here – that what's important is the small absolute difference of 0.15 mL instead of the relative difference of 67% – strikes me as, well, wrong.

The Board relied on In re Sinex, which did find that "substantially horizontal includes chamber that is inclined at 9 degrees," as the Board said. But I say Sinex doesn't really speak to the issue of whether it's relative or absolute values that matter in determining what's "substantial."

The issue in Sinex was: how much of an incline is still "substantially" horizontal? The Federal Circuit's predecessor, the CCPA, said that a 9% include was not, without explaining why. But I think we can all agree that a 45% incline is not substantially horizontal. The way I see it, a 9% incline is 9/45 = 20% more than horizontal. Thus, I read In re Sinex as saying that 20% more than X is outside the scope of substantially X.

I see see no reason to read Sinex as saying that 9 more than X is always outside of substantially X. What if X were 1000? Why would we say that 1009 is not substantially equal to 1000? I'd be inclined to say, to the contrary, 1009 is substantially equal to 1000.

I've looked, but don't see a case that is directly on point (I didn't look exhaustively since this question isn't important to the cases I work on.)

If you know of a case that really addresses "is substantially evaluated as a relative or an absolute," post a comment and let me know.

Friday, April 22, 2011

Today I'll return to my list of Top 10 Applicant Mistakes on Appeal. The last post in this series was Mistake #7: "Using attorney argument when evidence is required". (Split into two parts: Mistake 7.0 and Mistake 7.5.)

The most common form of evidence is an expert declaration under § 1.132. Today's post on Mistake #8 is also about declarations: "Using a declaration that amounts to opinion without factual support."

Ex parte Norman was an extreme example of a § 1.132 declaration with no factual support whatsoever. The declaration, which was submitted to overcome an obviousness rejection, merely stated:

I am a co-inventor of the above-identified Application. I am familiar with the Official Action dated September 24, 2003 and have thoroughly studied the prior art used to reject the claims in the Application. As a result of my long experience in the toy industry, I can unequivocally state that the prior art utilized to reject the claims in the Application does not render those claims obvious. Rejection of the claims is based on the use of hindsight, not actual teachings or suggestions gleaned from the prior art.

The Board found that "this conclusory assertion is of little or no value because Mr. Norman fails to set forth any facts underlying the opinion."

The Applicant in Ex parte Pruitt filed a § 1.132 declaration to overcome an obviousness rejection. The declaration discussed the teachings of the prior art, and even contained references to specific passages in the prior art:

16. In the BACKGROUND portion of the Elliott et a1 patent (Col. 1, lines 44-48), theinventors confirm that a single pair of rubber conditioning rolls with a herringbone rib pattern has problems feeding extremely thick or wet hay. When the rubber rolls get wet, they become slick and can't grip the hay as well.Therefore, the inventors in this patent state that one of the objects of their invention is "to provide a hay cutting machine which is less prone to plugging than others presently available" (Col. 1, lines 66-68). These inventors suggest solving this problem by providing a second pair of rubber rolls with a herringbone rib pattern and setting the tension lighter than in a "single-roller" conditioner to accomplish the same degree of conditioning (Col. 2, lines 1-4). This patent does not disclose the use of metal conditioning rolls of any kind.

However, the Board found the declarant's statement about rubber rolls to not be credible because it contradicted the plain teachings of the prior art, and because the declarant did not explain the discrepancy:

[W]e cannot ascertain the basis for Mr. Pruitt’s statement in paragraph 16 of the declaration that Elliott discloses the use of rubber rolls. We have reviewed the passages of Elliott cited by Mr. Pruitt and find no mention that the rolls are made from rubber. Mr. Pruitt does not provide any further explanation in his declaration for the basis for this assertion.

Ex parte Tydings was a reexamination appeal with claims directed to a urine drug screening system. The patentee submitted a § 1.132 declaration to overcome an obviousness rejection, but the Board found the statements were not supported by facts:

The declarants testify that the claimed assay assembly and the assembly claimed in the 620 patent function differently. Tydings, ¶¶ 13, p. 3; Hipple, ¶ 11, p. 3. Hipple also testifies that it would not have been appreciated that the up the wick flow would function and be operable. Hipple, ¶ 11, p. 3. The declarants, however, have not provided an explanation of how the claimed and 620 assemblies in fact function differently or why one skilled in the art would not have appreciated that arranging the contact point so the urine generally flows in an upward direction would not be operable. We do not give weight to the unsupported opinions on these points. Opinions unsupported by facts are entitled to little or no weight. In re Etter, 756 F.2d 852, 860 (Fed. Cir. 1985) (en banc).
(Emphasis added.)

Ex parte Early Childhood LLC was another reexamination appeal. The patentee filed a § 1.132 declaration to show the secondary consideration of commercial success. The declarant stated that “[t]he cot which is patented in the 6,345,400 patent . . . is a principal product of ELC . . . and comprises a significant portion of the $180,000,000 annual revenue and has been a huge commercial success.” The Board found the declaration insufficient because it did not "provide a detailed analysis of how the features of the cot enjoying these sales compares to features of the claimed cot." The Board further noted that "[m]erely stating that a product, even if it is the claimed product, is a 'significant portion' of annual revenue does not establish any of these factors [required to show commercial success]." The patentee offered as additional evidence an email "which states that cot covers with Velcro® enclosures have become 'standard' in Asia," but the Board found that this email did not address the commercial success factors either.

Tuesday, April 19, 2011

Takeaway: In Ex parte Fujimori, BPAI affirmed an obviousness rejection of a claim to a single chip supporting multiple wired Ethernet physical protocol sub-layers. No interaction between the protocol sub-layers was claimed. The Applicant argued that the primary wired Ethernet reference could not be combined with the secondary wireless Ethernet reference without changing the principle of operation of the primary reference. The Board disagreed, nothing that obviousness does not require the bodily incorporation of one reference into another. The Board concluded the claimed combination is "a simple arrangement
of old elements, with each performing the same function it had been
known to perform, yielding no more than one would expect from such an
arrangement."

The Examiner rejected the originally filed claims – which did not include the "signal equalization" limitation – as obvious over Applicant admitted prior art in view of a 10 Gigabit Ethernet whitepaper. According to the Examiner, the Background section of Applicant's specification taught everything but Fibre Channel operation. The Applicant argued that the references did not teach that the claimed functionalities were present in a CMOS sublayer.

The Examiner withdrew the obviousness rejection and rejected as anticipated by a integrated circuit datasheet published by Mindspeed. The Applicant amended to distinguish, by adding the "signal equalization" limitation to the PMD transmit/receive CMOS sublayer.

The Examiner changed the obviousness rejection to use a different secondary reference. The Mindspeed publication used as a primary reference disclosed an Ethernet transceiver having the three (protocol) sublayers, and all the claimed functionality except for signal equalization in the PMD tx/rx CMOS sublayer. As the new secondary reference, the Examiner used a reference teaching signal equalization in a PMD sublayer.

The Applicant argued that the secondary reference taught signal equalization in a different layer (XAUI tx/rx) than claimed (PMD tx/rx). The Applicant went on to argue:

In fact, Shi does not disclose or suggest any PMD sublayer characteristics or functionalities whatsoever. ... Therefore, the proposed combination of Mindspeed and Shi does not teach or suggest "a PMD transmit/receive CMSO sublayer supporting at least 10 Gigabit Ethernet operation, 10 Gigibit Fibre Channel operation, and signal equalization," such as recited in claim 1.

The Examiner switched the secondary reference again, to a draft proposal for a new Ethernet standard. The Applicant argued that the secondary reference was directed to a wireless protocol (802.16 or WiMAX), where 10 Gigabit Ethernet was a wired protocol. "Therefore, the electrical and protocol characteristics of the PHYs for the 10 Gigabit Ethernet protocol and the IEEE 802.16 protocol are completely different.

The Examiner maintained the rejection, and Applicant went to appeal. In the Appeal Brief, the Applicant argued:

Since Hunter relates to a wireless protocol and 10 Gigabit Ethernet relates to a wired protocol, Hunter does not (and cannot) disclose "a single-chip multi-sublaver PHY to support 10 Gigabit digital serial communications, said single-chip comprising a PMD transmit/receive CMOS sublayer supporting at least 10 Gigabit Ethernet operation . . . and signal equalization," as recited by Applicant's claim 1 (emphasis added).
Hunter cannot modify Mindspeed because Mindspeed relates to a wired protocol and Hunter relates to a wireless protocol with different electrical and protocol characteristics of the PHY. Any changes to Mindspeed using the teachings of Hunter will change the principal of operation of Mindspeed since Mindspeed and Hunter teach different PHY protocol characteristics.

The Board said the Applicant went wrong in assuming that the combination involved literally ("bodily") incorporating the wireless chip into the wired chip.

That is, the test for obviousness is not whether Hunter can be bodily incorporated into the structure of Mindspeed, but rather it would have been obvious to combine Hunter’s teachings that a PMD sublayer can be used to support signal equalization to the teachings of Mindspeed’s PMD sublayer that supports signal conditioning. ... [W]e conclude that such combination is no more than a simple arrangement of old elements, with each performing the same function it had been known to perform, yielding no more than one would expect from such an arrangement. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The skilled artisan would “be able to fit the teachings of multiple patents together like pieces of a puzzle” since the skilled artisan is “a person of ordinary creativity, not an automaton.” Id. at 420-21. Appellants have presented no evidence that supporting signal equalization (as discussed by Hunter) as Mindspeed’s signal conditioning was “uniquely challenging or difficult for one of ordinary skill in the art” or “represented an unobvious step over the prior art.” See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418-19).

My two cents: The lesson here: a claim to a combination of known elements is prima facie obvious over a combination of references that does not teach how to accommodate technical differences between the elements, as long as the claim doesn't capture how the differences are handled either. Here, even if there were differences in the "electrical and protocol characteristics" of Gigabit Ethernet's physical layer WiMAX's physical layer, so what? Nothing about electrical or protocol characteristics was expressed in the claims.

So if there is some technical magic involved to bridge the differences, put that magic in the claims. Otherwise, the PTO will assume that you did nothing more than place three existing protocol sublayers on the same chip.

Sunday, April 17, 2011

At issue in this case: what is the minimum that an Examiner must provide to make a prima facie rejection?

On appeal from the BPAI, the Applicant asked the Federal Circuit to require a rejection to do more than simply put the Applicant on notice as to the nature of the rejection as required by § 132. According to the Applicant, the Examiner should be required to first perform claim construction under the broadest reasonable interpretation, and then to provide enough explanation to bridge the gap between the claim and the bare teachings of the reference. According to Jung, if these two requirements aren't met, the burden hasn't shifted and the Applicant is not required to provide argument or evidence to overcome the rejection.

The Federal Circuit did not agree, and refused to require anything more than § 132 itself. The courte noted that the plain language of § 132 says the examiner must "notify the applicant," "stating the reasons for such rejection," "together with such information and references as may be useful in judging the propriety of continuing prosecution of his application." In Jung's particular case, the Examiner met these requirements and more:

Here, the examiner's discussion of the theory of invalidity (anticipation), the prior art basis for the rejection (Kalnitsky), and the identification of where each limitation of the rejected claims is shown in the prior art reference by specific column and line number was more than sufficient to meet this burden. ...
There has never been a requirement for an examiner to make an on-the-record claim construction of every term in every rejected claim and to explain every possible difference between the prior art and the claimed invention in order to make out a prima facie rejection.

My two cents: I wrote about this case last year (here). Not much to say about this decision. I didn't expect the Federal Circuit to buy Jung's arguments.

These were terrible facts to use in asking for the prima facie requirement to be retooled. First, the Examiner did a fine job of explaining his position. The Examiner even performed explicit claim construction. So in my opinion the rejection actually met Jung's own definition of a prima facie case.

Second, the policy aspect of Jung's argument amounted to "it's not fair to ask Applicant to put a position on the record if Applicant doesn't know what the Examiner is thinking." Yet the record in this case clearly shows that Jung did understand the Examiner's position, and the Applicant went on to argue the merits of the rejection.

As a patent prosecutor of course I'm personally disappointed that the Federal Circuit didn't give the prima facie case requirement more teeth. Prosecution would go much faster if the Examiner was required to explain how the claim elements map to features in the references (not to columns and line numbers). To be fair, prosecution would go much faster if Applicants actually explained how they were interpreting the claims and then made arguments that actually explained how references were different. The difference between the two sides is that when an Applicant puts this stuff on the record, it can adversely affect the patent in litigation. There is no analogous downside to the Examiner explaining his position on the record.

Wednesday, April 13, 2011

Yesterday's blog post (here) discussed Ex parte Parker, in which the BPAI affirmed an obviousness rejection for an introducer sheath (a medical device used in angioplasty). The Board reached the conclusion of obviousness on two alternative grounds: the Examiner's substitution rationale; and their own "design trade off" rationale.

Yesterday's post focused on how Applicant admissions helped the Board to reach the conclusion of "obvious design trade off." Today I'll discuss the dissenting opinion in Parker, which found error in the Examiner's substitution rationale.

The Examiner offered this rationale for obviousness:

Horrigan et al. do not disclose the use of a flat wire coil, a round wire coil or a braided wire coil as a reinforcement means. Park et al. teach a catheter section or sheath with equivalent forms of stiffening members or reinforcement for kink resistance, i.e., a flat wire coil, a round wire coil and a braided wire coil.
It would have been obvious ... to have substituted the wire braid 35 of Horrigan et al. with a braided wire coil, a flat wire coil or a round wire coil as disclosed by Park et al. to have facilitated the manufacture of the catheter or sheath with a diameter suitable for application in an environment of increasingly small diameters.
(Internal citations omitted.)

Now, the strength of the substitution rationale depends on just how equivalent braids and coils really are. The dissent found that the Examiner's premise of equivalency was based on reading statements in the secondary reference (Park) in isolation.

Here's the statement which the Examiner relies on for equivalency:

[T]he structure of this ribbon coil-based catheter section [in FIG. 5]
and the similar variation (224) shown in FIG. 6 using a wire or
strand-based unwoven coils (226) are acceptable alternatives to the
preferred variation shown in FIG. Nos. 3 and 4.

The dissent says that Park, when read as a whole, merely teaches the interchangeability of braids and coils in the specific context of Park's invention. The dissent says that Park is really about using a super-elastic material for the reinforcing mechanism, where the material changes shape when heat is applied. It's true that Park discloses the reinforcing mechanism can be a coil or a braid. But that doesn't mean that coils and braids are truly interchangeable -– only that the choice doesn't matter for Park's invention because Park's invention is about the material itself.

This same point was made (quite elegantly) by the Applicant in the Reply Brief:

[A teaching] that discusses the possibility of using a variety of reinforcements under conditions in which the particular type of reinforcement is of little significance to the teaching at hand, does not provide a skilled artisan with sufficient guidance to arrive at the invention claimed herein ...

A substitution rationale is strongest when it's simple substitution – when switching from braid to coil doesn't make a difference. Without such a teaching – or better yet, with a teaching that says it does make a difference – the rationale is weakened. Here, the Examiner specifically relied on Park to show that coils and braids were equivalent. I say the Applicant was on the right track in attacking this premise. The fact that the majority of judges didn't see it that way doesn't mean it's not a valid argument. I'd say the fact that the dissent was convinced shows the argument has some merit.

Tuesday, April 12, 2011

Takeaway: In an application for a medical device, the Applicant offered declaration evidence explaining why a claimed feature was superior to the feature in the primary reference in the obviousness rejection. The Board found that these admissions supported a conclusion of obviousness, since they demonstrated why a POSITA would substitute the feature missing from the reference to produce the claimed invention. (Ex parte Parker.)

The technology on appeal involved an "introducer sheath," used in medical procedures like angioplasty. The independent claim on appeal included an inner tube, a wire coil wound around the inner tube, and two outer tubes of differing hardness.

The Examiner rejected under § 103, using a primary reference (Horrigan) that disclosed everything in the claim, except it used a wire braid rather than a wire coil. The secondary reference (Park) disclosed a sheath with "various forms of braid and coil reinforcements," along with "the equivalence of a braid or a coil or a combination of one or more of each for reinforcement of an intravascular device for use in an environment of increasingly small diameters." The Examiner used this to advance the substitution rationale:

It would have been obvious ... to have substituted the wire braid 35 of Horrigan et al. with a braided wire coil, a flat wire coil or a round wire coil as disclosed by Park et al. to have facilitated the manufacture of the catheter or sheath with a diameter suitable for application in an environment of increasingly small diameters.

Before appeal, the Applicant submitted declaration evidence to show that coils and braids are not equivalent or interchangeable. The declarations also explained how computer simulation using finite element analysis had shown the claimed coil was superior to the braid described in the primary reference. The Examiner was not persuaded, so the Applicant appealed.

In the Appeal Brief, the Applicant referred to the statements in the declaration, and explained their significance as follows:

Clearly, the [finite elements analysis] test showed that the sheath having a coil reinforcement has bending angles at which the sheath having a braid reinforcement would be unusable. This difference can be critical when attempting to position a medical interventional device, such as a stent, at branched or otherwise tortuous area of the vasculature. In many such cases, placement utilizing a coil-reinforced sheath would be successful, while an attempted placement with a braid-reinforced sheath would fail.

The Board agreed with the Examiner's substitution rationale, finding that "the use of a wire coil in an introducer sheath involves the simple substitution of one type of reinforcement (a braid) for another known reinforcement in order to achieve the predictable result of a sheath of small diameter for use in navigating small blood vessels."

The Board noted the Applicant's disagreement with the Examiner on whether or not the secondary reference (Park) taught the equivalence of braids and coils as "alternative types of reinforcement structures utilized in intravascular devices." However, the Board found that even if the Examiner's finding of equivalence was in error, it would be obvious to balance design trade offs to select either a coil or a braid for a reinforcement. The Board based this, in part, on the Applicant's admissions that differences between coils and braids were well understood:

Appellant admits that the properties of and differences between the two types of support structures were known by persons of ordinary skill in the art. See App. Br. 10 (a braid’s torque transmitting ability “is well known to those skilled in the art”); Reply Br. 4 (“Appellant repeatedly emphasized, with both argument and evidence, that those skilled in the art recognize that there is a distinct difference between various types of reinforcements utilized in medical devices.”); Oral Hearing Transcript at 4:16-21 (discussing the high level of knowledge in the art at the time of the invention); id. at 15:12 – 16:5 (same); Spec. 2:1-7 (paraphrasing Parker, col. 1, l. 64 – col. 2, l. 4, and describing that reference as disclosing a sheath with improved kink resistance due to a coil reinforcement). Accepting as fact that ordinary artisans recognized that a coil reinforcement provides predictable and markedly better results than a braid, this, in itself, is a reason to modify Horrigan’s braid-reinforced device. At most, Appellant’s arguments suggest that the Examiner’s proposed modification would require one of ordinary skill in the art to balance certain design trade-offs in selecting the type of reinforcement. However, this does not render the claimed invention non-obvious. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 421 (“If [pursuing known options within the ordinary artisan’s grasp] leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”)

My two cents: There's a lot going on in this case – seven Office Actions before the case made it to the Board. The Applicant did a lot right. For starters, the Applicant pulled the case from appeal the first time and introduced declaration evidence. The first three responses included a lot of sweeping statements about the art which could be considered "mere attorney argument" by the Board. After that, the Applicant started submitting declaration evidence – a total of four different 1.132 declarations by four different non-inventor experts over the course of the next three years of prosecution.

Today's post focuses on one narrow issue: how the Applicant's argument and evidence about advantages – designed to overcome an obviousness rejection – apparently did just the opposite.

The Applicant fought the same combination of references since the very first Office Action. The substitution rationale was also present since the first Office Action: "mere substitution of one functional equivalent for another" and "selection of any of these known equivalents would provide a cathether section with improved kink resistance as taught by [primary reference.]"

I think the Applicant got stuck, very early in prosecution, on the Examiner's statements about the equivalence of braids and coils. And in refuting the equivalence, the Applicant walked into what turned out to be an obviousness trap. OK, there are differences between coils and braids when used in stents. OK, a coil like the one claimed by Applicant is superior. But if those differences are known (and Applicant admitted they were) then picking the appropriate one can be viewed as a design trade off like those made by engineers every day, as opposed to an invention worthy of a patent. Worse yet, if the superiority of a coil is known (and Applicant's background admitted this in describing another prior art reference) then it's not even a trade off to be investigated by engineers – this known superiority can be viewed as an actual reason to modify the primary reference to use the superior coil rather than the inferior braid.

There's a lot more to this case. There was a dissenting opinion that offers another viewpoint, one which I find compelling. I'll discuss the Ex parte Parker dissent in a future post.

Postscript: The Applicant has appealed the BPAI decision to the Federal Circuit. The assignee is Cook Medical.

EFS-Web has been updated to process several types of petitions automatically. See the PTO notice here. You fill out an online form and the petition is granted in real time by EFS software, without action by a human at the Petitions Office. The list of auto-granted petitions includes Withdraw from Issue and Withdraw as Attorney. Auto granting of Withdraw from Issue is particularly helpful, because under the old procedure the petition was ineffective unless it was "actually received and granted by the appropriate officials before the date of issue."

The PTO is working on new regulations to change Patent Term Adjustment (PTA) and Patent Term Extension (PTE). (See Federal Reigster notice here.) The biggest change appears to be handling of appeals to the BPAI. PatentDocs reports (here) that under the proposed new rules, reopening of prosecution by the Examiner after a Notice of Appeal results in an increase in term via the PTA or PTE adjustment.

PharmaPatents reports here on a recent district court lawsuit challenging the PTO's calculation of PTA. This tidbit from the post highlights how PTA is affected by a Non-Compliant Response:

PTA penalty for a "non-compliant" response is particularly harsh,
because no matter how long the USPTO takes to notice the alleged defect
in the response, and no matter how promptly the defect is corrected, the
PTA rules charge Applicants with "delay" for the entire time period
from the filing of the original response until the filing of a corrected
response.

Friday, April 8, 2011

Takeaway: In Ex parte Ouelette, the BPAI reversed an anticipation rejection that relied exclusively on a drawing in foreign language reference. "The figures are so small and blurred as to be unreadable so that the
exact position and operation of the formers 7 cannot be determined. The
Niwa written disclosure does not provide assistance in this regard."

The Examiner rejected under § 102(b) using only the drawings from a Japanese patent (shown below). In the Final Office Action, the Examiner alleged that the patent showed "opposing upper and lower lateral guides 7 that are inclined toward each other (see Figure 1 and compare Figures 2-4) to position the film on the sides of the objects." [Reference numbers 7 shown in red below.]

On appeal, the Applicant made several distinctions. One of the distinctions was that "the only diagonally oriented edges of the members 7, 9 disclosed by the Japanese publication overlap each other, and do not oppose each other."

In the Response to Argument section of the Answer, the Examiner explained that the Applicant had misinterpreted the final rejection:

It should first be noted that element 9 is not a guide surface, as mentioned by applicant, and it was not referred to in the Final Rejection but as shown in figure 1 of the publication 9 is plate positioned under the film (also see Figures 2-4). The rejection referred to the two guide surfaces 7 that are inclined upward and downward to create the film folds.

The Examiner then clarified the rejection in the body of the Answer:

The [guides] are vertically opposed each other in that they start out in the upstream position in spaced and opposite relations, i.e. upper and lower positions, and end up in an overlapped position and opposite each other, i.e. lower and upper positions, as they pass each other to perform the folding of the two edge of the film. Furthermore, the guide surfaces can be considered to be horizontally opposed each other in that they are facing each other in parallel planes.

The Applicant filed a Reply Brief, noting that:

These comments [in the Answer's Response to Arguments section] point out the ambiguousness of the Japanese reference. In Figure 2 of the reference, it appears that the reference No. 9 is being directed to one of the four angled elements arranged adjacent the four corners of the object 4. One of the angled elements, the element adjacent the upper right-hand corner of the object 4 shown in Figure 2 is labeled with the reference No. 7. The other three angled elements apparently are not labeled. The drawing figures of the reference are so ambiguous, it is not clear as to whether all four of the angled elements are identified by the reference No. 7.

The Applicant further argued that "in view of the ambiguousness of the Japanese reference alone, the reference is not a valid reference for an anticipation rejection."

After the Reply Brief was filed, the Examiner provided a translation of the Japanese reference for the record.

In the Decision on Appeal, the Board made the following Finding of Fact:

The figures do not clearly depict the other elements of the device. Specifically, the figures are so small and blurred as to be unreadable so that the exact position and operation of the formers 7 cannot be determined. The Niwa written disclosure does not provide assistance in this regard.

The Board reversed the rejection, explaining that:

Any conclusions about the position and function of the formers 7 can only be made by speculation" A reference relied on to prove unpatentability must be so clear and explicit that those skilled in the art will have no difficulty in ascertaining its meaning. See In re Turlay, 304 F.2d 893, 899 (CCPA 1962).

My two cents: I don't handle a lot of mechanical cases, but two things seem clear to me. One, spatial and positional relationships between components are often key to the claims. Two, drawings are often very important in showing these relationships, but sometimes a written description is helpful in explaining the drawings. Here, the drawing included lots of features, which made it hard to see what the reference numbers pointed to, and there was no translation provided before appeal. So it makes sense to me that the Board found this rejection deficient.

I'm disappointed that the Board didn't even mention that the Examiner didn't
provide a translation until after the Reply Brief. The Board should have slammed
the Examiner for this oversight.

Then again, don't expect the Board to do your work for you. The Applicant should have demanded a translation of the Japanese reference, citing MPEP 706.02. You can't really force the Examiner to comply, but it can't hurt, right? See my post "Dealing With Foreign References".

The claimed subject matter was directed to a medical device, such as a feeding tube. Claim 1, a representative claim on appeal, read:

1. A medical device configured for dynamic movement through a body canal toward an interior target site and removal therefrom, said device comprising
an elongate tubular member having a plurality of distal projections disposed on an exterior surface thereof,
said projections extending outwardly from the exterior surface of the tubular member a distance sufficient to engage an interior surface of the body canal during bodily contractions therein,
said distal projections being configured so as to promote ingress of said device in response to said contractions,
at least some of said projections being formed of a composition that is soluble under bodily conditions at said body canal.

An example embodiment is shown below, with distal projections 16.

The Examiner rejected claim 1 as obvious, alleging that the primary reference (Reydel) taught a medical device with distal projections as claimed, except for the soluble composition. The Examiner relied on the secondary reference (Anders) for teaching a catheter having a portion that is formed of a composition soluble under bodily conditions. The Examiner alleged that using Anders' soluble composition to form Reydel's distal projections would be obvious "to provide a composition that will dissolve in bodily fluids" as taught by Anders. The Examiner further alleged that "it is within the general skill of a worker in the art to select a known material based on its suitability for the intended use as a matter of obvious design choice."

The Appellant argued that Reydel's tube differed from the claimed tube because although the projections are useful for inserting the tube, the projections impede removal of the tube. The Applicant argued that the claimed invention improves on Reydel's tube by providing a mechanism for removing the projections once the tube is placed: the projections dissolve. Thus, the invention "addresses difficulties that may be encountered when attempting to withdraw the tube." The secondary reference, Anders, disclosed a needle with a soluble tip. But the problem addressed by Anders was much different: protecting healthcare workers from needle sticks.

The Board agreed with the Applicant and reversed the obviousness rejection. The Board found that "the Examiner did not establish a reason based on the evidence in the record for combining Reydel with Anders to result in a medical device comprising projections formed of a composition that is soluble in a body canal."

The Board first noted the problem addressed by, and the solution provided by, the claimed invention: unidirectional projections that promote ingress but then dissolve to eliminate an impediment to egress. The Board then contrasted this with the problem and solution of Reydel – bidirectional projections that assist in ingress and remain during egress without causing trauma. Finally, the Board noted that Anders addressed yet another problem, needle stick, that can occur outside the body after removal of the device. The Board concluded that "the Examiner has not shown through evidence that, at the time of the invention, it would have been desirable to have a medical device including a tubular body with exterior projections that are present only during ingress, much less to use dissolvable flaps as a solution."

My two cents: I haven't seen many cases where the Board used this sort of "problem" analysis to decide obviousness.

The Board focused on the teachings of the references as a whole rather than just the specific features used by the Examiner. The Board found that the "bidirectional" projections in Reydel functioned differently than the Applicant's projections, and used this in finding non-obviousness. This argument wouldn't have gone far in an anticipation rejection. First of all, the claims didn't recite the unidirectional behavior, so the feature is irrelevant. Second, the fact that a reference teaches more than is claimed – Reydel's projections were flexible and thus "bidirectional" – is irrelevant to anticipation. Yet the Board did looked to these aspects of Reydel in deciding whether or not a POSITA would combine Reydel with Anders.

The Board did not comment on the Examiner's "obvious design choice to select a suitable material" rationale. Perhaps the factors which the Board focused on outweighed the suitable material rationale. In other words, it's obvious to select a suitable material unless there are reasons why it's not obvious, such as those the Board found.

The Board also didn't comment on the Examiner's circular rationale for combining: it would be obvious to add claimed feature A (soluble projections) to the primary reference to produce the result provided by feature A (soluble projections).

About Me

I'm a registered patent attorney, and a partner at the law firm of Cantor Colburn LLP. My practice focuses on patent prosecution, primarily in the technology areas of networking, data communications, operating systems, and application software.

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